BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SR- MODEL 230

    K Number: K842289 · Decision Jul 25, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    149
    Registration Numbers
    149
    Same Product Code
    847
    Applicant Total
    8
    Review Days
    47

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    Basic Information

    Device Name
    SR- MODEL 230
    K Number
    K842289
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Hirata Sangyo Co. USA, Inc.
    Date Received
    June 8, 1984
    Decision Date
    July 25, 1984
    Product Code
    FRN
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FRN Pump, Infusion

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    Other Clearances by Hirata Sangyo Co. USA, Inc.

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    K832686 MULTIPLE MANUAL SURGICAL INSTRUMENTS
    K831583 GP-303
    K821989 NON-STETHO 7, UM-15TP
    K822571 SYRINGE PUMP